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CTRI Number  CTRI/2024/03/064368 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic medicine Morgan pure in controlling asthma 
Scientific Title of Study   Efficacy of the homoeopathic medicine Morgan pure in LM potencies in asthma control in adolescents and adults: A series of n-of-1 trials 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1304-1015  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sourav Bera 
Designation  Postgraduate Tainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, 12, Gobinda Khatick Road, Tangra, Kolkata 700046

Kolkata
WEST BENGAL
700046
India 
Phone  8420276193  
Fax    
Email  souravbera167@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Soumya Bhattacharyya 
Designation  Lecturer 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, 12, Gobinda Khatick Road, Tangra, Kolkata- 700046

Kolkata
WEST BENGAL
700046
India 
Phone  9836998171  
Fax    
Email  soumya.bh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Soumya Bhattacharyya 
Designation  Lecturer 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, 12, Gobinda Khatick Road, Tangra, Kolkata- 700046

Kolkata
WEST BENGAL
700046
India 
Phone  9836998171  
Fax    
Email  soumya.bh@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046 
 
Primary Sponsor  
Name  D. N. De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Kolkata 700046, West Bengal  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sourav Bera  D. N. De Homoeopathic Medical college and Hospital  Dept. of Materia Medica, OPD no. PG2, Medicine (room 1), Pediatrics (room 2), 12, Gobinda Khatick Road, Kolkata- 700046, West Bengal
Kolkata
WEST BENGAL 		 8420276193

souravbera167@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine Morgan pure in LM potencies plus concomitant care  Intervention is planned as administering Morgan pure in 50-millesimal or LM potencies, as appropriate to the case or conditions. A single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 80 mL of distilled water with the addition of 2 drops of 90% v/v ethanol, and 14 doses are marked on the vial. After 10 uniformly forceful downward strokes to the vial, each dose of 5 mL is instructed to be mixed with 45 mL normal water in a clean cup, to stir well, to take 5 mL of it orally on a clean tongue, and to discard the rest of the liquid from the cup. All medicines and sundry items will be procured from a Good Manufacturing Practice-certified firm. The baseline prescription will start with the LM1 potency in every case. Potencies will be increased during follow-up after a consensus among the physicians. Both medicines and placebos will be repacked in identical glass bottles and labeled with code, name of medicine, and potency, and will be dispensed according to the random number list. A single medicine will be prescribed on each occasion on individualization of the homeopathic medication for each case will be based on analyzing the totality of symptoms for those that stand out as characteristic of the case. Materia medica will be consulted, and a consensus will be arrived at among three homeopaths for the final selection of the medicine and dosage. Concomitant care- Yoga as per the advice of a yoga therapist and standard pharmacological care of asthma as per the advice of the pulmonologist. Duration of therapy: 102 days. 
Comparator Agent  Placebos that is identical in appearance to the verum plus concomitant care  Placebos will be identical in appearance to the verum. Patients will be examined similarly by the three homeopaths as in the verum group. A single non-medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 80 mL of distilled water with the addition of 2 drops of 90% v/v ethanol, and 14 doses are marked on the vial. After 10 uniformly forceful downward strokes to the vial, each dose of 5 mL is instructed to be mixed with 45 mL normal water in a clean cup, to stir well, to take 5 mL of it orally on a clean tongue, and to discard the rest of the liquid from the cup. Patients will be examined similarly by the three homeopaths as in the verum group. All sundry items will be procured from a Good Manufacturing Practice-certified firm. Concomitant care- Yoga as per the advice of yoga therapist and standard pharmacological care of asthma as per the advice of the pulmonologist. Duration of therapy: 102 days. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Age between 12-21 years(adolescent) and 21-65 years.
ii. Patients of either sex or transgender
iii. Patients with asthma (ICD -11 code CA23) are confirmed by the following criteria-
HISTORY OF TYPICAL VARIABLE RESPIRATORY SYMPTOMS: Wheeze,
shortness of breath, chest tightness and cough (Descriptors may vary between cultures
and by age). Symptoms or features that support the diagnosis of asthma-
✓ More than one type of respiratory symptom (in adults, isolated cough is seldom due to
asthma)
✓ Symptoms occur variably over time and vary in intensity
✓ Symptoms are often worse at night or on waking
✓ Symptoms are often triggered by exercise, laughter, allergens, cold air
✓ Symptoms often appear or worsen with viral infections
CONFIRMED VARIABLE EXPIRATORY AIRFLOW LIMITATION:
Documented excessive variability in lung function (one or more of the following):
The greater the variations, or the more occasions excess variation is seen, the more confident the diagnosis. If initially negative, tests can be repeated during symptoms or in the early morning.
Positive bronchodilator (BD) responsiveness (reversibility): Adults: increase in FEV1 of greater than 12% and 200 ml. (greater confidence if the increase is greater than 15% and greater than 400 mL).
Measure change 10-15 minutes after 200-400 mcg salbutamol (albuterol) or equivalent.
✓ Excessive variability in twice-daily PEF over 2 weeks: Adults average daily diurnal PEF
variability greater than 10%.
Documented expiratory airflow limitation: At a time FEV1 is reduced (e.g. during
testing above), confirmed that FEV1/FVC is also reduced compared with the lower limit
of normal (it is usually greater than 0.75-0.80 in adults).
iv. Indication of Morgan pure-
✓ History of pneumonia or bronchopneumonia; never well since. Bronchitis and
asthma(self-reported)
✓ At least 3 important symptoms from the symptomatology of Morgan pure.
✓ Differentiation and comparison with other drugs with the help of the literature.
✓ Individualization of the case to be ratified by consensus among three prescribers. 
 
ExclusionCriteria 
Details  i. Known lower respiratory tract disease other than asthma.
ii. Not providing written informed consent and/or assent voluntarily to participate in the study.
iii. ICD-11 code- allergic asthma with status asthmaticus (CA23.01), non-allergic asthma, with status asthmaticus (CA23.11), aspirin-induced asthma (CA23.20), unspecified asthma with status asthmaticus (CA23.31).
iv. Severe persistent asthma (FEV1 less than 60%)
v. Need for immediate ICU care
vi. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting the quality of life or any organ failure.
vii. Tobacco chewing and/or smoking, alcoholism and/or any other form(s)of substance abuse and/or dependence.
viii. Self-reported immune-compromised state.
ix. Already undergoing homoeopathic treatment for chronic diseases other than asthma within the last 1month.
x. Simultaneous participation in any other clinical trial. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Asthma Control Test(ACT) score   Baseline, every 17 days, up to 102 days 
 
Secondary Outcome  
Outcome  TimePoints 
Spirometry measures: FEV1 (Forced Expiratory Volume in 1 second), FVC (Forced vital capacity), FEV1/FVC and PEF (Peak Expiratory Flow)  Baseline, every 17 days, up to 102 days 
AQLQ(S)-(Asthma Quality of Life Questionnaire for 12 years and older)  Baseline, every 17 days, up to 102 days 
Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2)  Baseline, every 17 days, up to 102 days 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [souravbera167@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   Asthma is a significant non-communicable disease globally with major public health consequences for both children and adults with high morbidity, and mortality in severe cases. Asthma is a prevalent major non-communicable disease that significantly affects the quality of life for many. The worldwide prevalence of asthma is estimated to be around 300 million people, and it is projected that an additional 100 million may be impacted by the condition by the year 2025. The national burden of asthma is estimated by the Indian Study on Epidemiology of Asthma, Respiratory Symptoms, and Chronic Bronchitis in Adults (INSEARCH) to be 17.23 million, with an overall prevalence of 2.05%. Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. it is defined by the history of respiratory symptoms, such as wheezing, shortness of breath, chest tightness, and cough, that vary over time and intensity, together with variable expiratory airflow limitation. This study attempts to identify the efficacy of homoeopathic medicine Morgan pure in asthma control in adolescents and adults after 102 days of intervention. This study is aimed to detect the difference between the groups Morgan pure and placebo group in the ACT (Asthma Control Test) questionnaire, spirometry measures – Forced Expiratory volume in one second (FEV1), FVC (Forced vital capacity), FEV1/FVC, PEF (Peak Expiratory Flow), AQLQ(S)-(Asthma Quality of Life Questionnaire for 12 years and older), and MYMOP-2(Measure Yourself Medical Outcome Profile) questionnaire in treatment of asthma over 102 days of intervention. A series of double-blind, randomized, placebo-controlled n-of-1 trials will be conducted on 21 adults who are suffering from asthma at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Group differences will be calculated in intention-to-treat and per-protocol approaches. Results will be published in scientific journals. 
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